Albuterol Sulfate Solution
FDA Recall NDC 0487-9501

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 4 recorded enforcement report(s) associated with Albuterol Sulfate (NDC 0487-9501). A significant event, classified as Class II, was initiated on Apr 13, 2022 by Nephron Pharmaceuticals Corporation. The reported reason for this action was: "cGMP deviations: Temperature abuse"

This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.

Reported Recall Events

D-1020-2022TERMINATEDD-1019-2022TERMINATEDD-66462-001TERMINATEDD-1446-2012TERMINATED

April 2022 Class II Recall: cGMP deviations

Recall Number
D-1020-2022
Class II Terminated
Reason for Recall
cGMP deviations: Temperature abuse
Initiated
Apr 13, 2022
Reported
Jun 15, 2022
Quantity
96 pouches

Recall Profile & Regulatory Data

Event ID
89646
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Nov 30, 2023
Product Description
Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 25 X 3mL unit-dose vials, Rx only, MFG by: Nephron Pharma, NDC 0487-9501-25
Batch or Lot Expiration Information
Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Affected Packages Involved in this Recall
0487-9501-25Product
0487-9501-03Product
0487-9501-60Product
0487-9501-01Product

April 2022 Class II Recall: cGMP deviations

Recall Number
D-1019-2022
Class II Terminated
Reason for Recall
cGMP deviations: Temperature abuse
Initiated
Apr 13, 2022
Reported
Jun 15, 2022
Quantity
23 pouches

Recall Profile & Regulatory Data

Event ID
89646
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Nov 30, 2023
Product Description
Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 5 x 3 mL unit-dose vials, Rx only, Manufactured by: Nephron Pharma, NDC 0487-9501-03
Batch or Lot Expiration Information
Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Affected Packages Involved in this Recall
0487-9501-25Product
0487-9501-03Product
0487-9501-60Product
0487-9501-01Product

October 2013 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-66462-001
Class II Terminated
Reason for Recall
Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.
Initiated
Oct 02, 2013
Reported
Oct 30, 2013
Quantity
689,568 cartons

Recall Profile & Regulatory Data

Event ID
66462
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Nephron Pharmaceuticals Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Aug 21, 2015
Product Description
Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials per carton, Manufactured By: Nephron Pharmaceuticals Corporation, Orlando, FL 32811, NDC 0487-9501-25
Batch or Lot Expiration Information
Lot# Lots #: A3A33A, A3A33B, A3A34A, A3A35A. A3A36A, A3A37A, A3A38A, Exp 06/15; A3A40A, A3A41A, A3A42A, Exp 07/15
Affected Packages Involved in this Recall
0487-9501-25Product
0487-9501-03Product
0487-9501-60Product
0487-9501-01Product

June 2011 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-1446-2012
Class II Terminated
Reason for Recall
Lack of Assurance of Sterility
Initiated
Jun 22, 2011
Reported
Aug 15, 2012
Quantity
56,028 cartons

Recall Profile & Regulatory Data

Event ID
62604
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Nephron Pharmaceuticals Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Nov 15, 2012
Product Description
Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporation, Orlando, FL 32811, NDC 0487-9501-60.
Batch or Lot Expiration Information
Lot# : A0654A, Exp 07/12; A0A62A, Exp 10/12
Affected Packages Involved in this Recall
0487-9501-25Product
0487-9501-03Product
0487-9501-60Product
0487-9501-01Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.